Launch of GraftAssure and Market Expansion
Successfully launched GraftAssure, a research use-only kidney transplant test, with leading transplant centers. The test has expanded the total addressable market by up to 20% and is expected to contribute to meaningful market growth over the next five years.
Strategic Partnership with Bio-Rad Laboratories
Secured a key strategic partner in Bio-Rad Laboratories, which has participated in all three equity funding rounds over the last year. Bio-Rad's support is expected to mitigate expenses and assist in clinical trial and commercialization efforts.
Medicare Claims Expansion and Regulatory Progress
Achieved Medicare claims expansion to monitor high-risk transplant patients and had a positive pre-submission meeting with the FDA, preparing for final submission later this year.
Financial Performance and Fundraising Success
Reported Q4 pharma services revenue of $1.5 million with a gross margin of 40%. Ended the year with $10 million in cash and raised an additional $29 million in February through a clean transaction with no incentive warrants or discounts.
Clinical and Scientific Advancements
Published a groundbreaking study in the New England Journal of Medicine, leading to FDA breakthrough designation for felzartamab. Demonstrated assay's ability to detect organ rejection 11 months ahead of standard protocols.
Strong Team and Operational Efficiency
Strengthened leadership team with new CFO Andrea James and Consulting Chief Medical Officer Dr. Paul Billings. Continued focus on operational efficiency, with outgoing cash flow favorable to targeted spend.